MAUDE Adverse Event Report: MENTOR SILICONE BREAST IMPLANTS

Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Codes	Fatigue (1849); Anxiety (2328); Depression (2361); Numbness (2415); Patient Problem/Medical Problem (2688); No Code Available (3191)
Date of Event	10/23/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Have mentor breast implants.Brain fog, anxiety, depression, numbness, sore, fatigue, loss of ability.

• Brand Name: SILICONE BREAST IMPLANTS
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6812690
• Report Number: MW5071745
• Device Sequence Number: 9330032
• Product Code: FTR
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 08/21/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 51 YR
• Patient Weight: 50